Roche’s Ocrevus MS drug approved in EU

Roche’s star multiple sclerosis (MS) drug Ocrevus (ocrelizumab) infusion has been approved in Europe, the first and only approved disease-modifying drug for a debilitating form of the disease.

EU approval was a formality after Ocrevus won backing from the CHMP regulatory committee in November.

Ocrevus is now the only disease-modifying drug for people in the EU with early primary progressive MS.

It has also been approved in relapsing forms of MS, where it will compete against a host of already approved rivals, such as Biogen’s Tecfidera (dimethyl fumarate) pill, and injected drugs, such as Merck KGaA’s Rebif (interferon beta-1a).

EU approval is based on clinical trial data that shows it is a significant improvement over Rebif in terms of relapse rates and disease progression, and increasing the chance of a patient having no evidence of disease activity by up to 89% in one study.

Trial data also shows Ocrevus is the first drug to slow disability progression and reduce signs of disease activity in the brain, as measured by MRI scans, compared with placebo, based on three-year follow up.

Ocrevus also has a very patient-friendly dosing schedule as it is administered once every six months.

Approved in the US in March, it has already been a hit with patients and subscribers in a very competitive market.

Nine-month sales figures, covering the period from Ocrevus’ launch until the end of September, show revenues from Ocrevus were around $500 million, based almost entirely on the US approval in the same indications.

Trials also showed that patients did not develop the brain disease progressive multifocal leukoencephalopathy (PML), a rare but deadly condition associated with use of Biogen’s competitor in relapsing disease, Tysabri (natalizumab).

Although one patient treated with Ocrevus has reportedly developed PML, Roche blamed this on previous treatment with Tysabri.

Gavin Giovannoni, professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London, said, “Until Ocrevus, people with primary progressive MS, who often have to rely on a cane or wheelchair, give up work or have carers look after them, have not had an approved treatment to slow the progression of their disease.

“People with relapsing forms of MS often have to make difficult trade-off choices between safety and higher efficacy. Ocrevus is given every six months without the need for onerous monitoring, which we hope will allow people to live their lives without thinking about their treatment every day or every week.”